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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K990322
Device Name PERRY HUMERAL NAIL
Applicant
Pioneer Surgical Technology
375 River Park Circle
Marquette,  MI  49855 -0627
Applicant Contact BURNS SEVERSON
Correspondent
Pioneer Surgical Technology
375 River Park Circle
Marquette,  MI  49855 -0627
Correspondent Contact BURNS SEVERSON
Regulation Number888.3020
Classification Product Code
HSB  
Date Received02/02/1999
Decision Date 04/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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